Patient in-the-loop participatory care and monitoring

ABSTRACT

Methods and systems for patient participatory care and monitoring are provided for applications including respiratory care, ECG monitoring, capnography, infusion pump alarm prevention/management, pressure sore prevention, incentive spirometry, consciousness monitoring during sedation, pain management and other care and monitoring modalities. A patient in-the-loop system includes an input interface for receiving data acquired from a monitoring, controlling or sensing device, a storage device for storing the data at a first location, and a processor for analyzing artifacts in the data and determining whether the patient provided a deliberate action with respect to the device as a response to a prompt or query. The processor can further initiate a variety of prompts and/or output queries stored in the storage device at a second location to the patient. The data derived from these patient-in-the-loop techniques are formatted to be received and interpreted by electronic medical record and electronic record keeping systems.

BACKGROUND

Currently, many healthcare assessments and interventions require thepresence or active involvement and/or the diligence or attention of aclinician. Examples include the assessment of consciousness or lackthereof (whether a patient responds or does not respond to a non-noxiousstimulus) and the assessment and documentation of patient comfort orpain score. Other examples include an intervention involving a requestto bed-ridden patients to periodically take a deep breath to improvelung status and the intervention involving a request to bed-riddenpatients to periodically shift their weight to prevent pressure sores.

A clinician may also be called upon to respond to alarm conditions ofpatient monitors in situations where the alarm is a result of a patientmoving too much or positioned in a manner that obstructs a reading orcreates a kink in tubing. These types of alarms may occur as high as 700times per patient per day in some settings leading to “alarm fatigue”due to being called in to, for example, ask a patient to move less toeliminate/reduce motion artifacts during electrocardiography (ECG) orpulse oximetry or adjust their position to remove a kink or otherobstruction in intravenous (IV) tubing.

Providing general hospital and pain management care, as well as pressuresore prevention and other quality of care metrics are deemed importantin the healthcare environment. In cases where a healthcare worker orprovider may not be or is suspected not to be compliant with patientcare guidelines, such as providing sponge baths on a periodic basis, thepatient can be asked as a quality control measure if a sponge bath wasgiven. Similarly, consciousness monitoring during conscious sedation iscurrently performed by a clinician engaging in idle chit chat with thepatient to verify that the patient is conscious.

As one example, the consciousness of a patient is an important factorfor administering sedation as well as for monitoring head injuries.Typically, as a first assessment of consciousness, a patient's verbalresponse or actions in response to a query or prompt is used to indicatewhether the patient is awake and conscious. However, when a patient isimmobilized or cannot verbally communicate due, for example, tointubation, or the patient being mute or for unimpaired patients, aclinician being absent or otherwise preoccupied, other means are neededto assess the patient's care including consciousness.

Current systems for determining consciousness of a patient provide aswitch or button for a patient to depress in response to a query orprompt. For example, if the patient is awake and conscious, the patientpresses the button or toggles a switch in response to the query orprompt, thereby communicating consciousness. If no button press orswitch toggle is registered within a set time period from the query orprompt, the patient is presumed to be unconscious.

BRIEF SUMMARY

Methods and systems are disclosed herein for enhancing patient care andpatient safety by empowering patients—and even heath care devices—withthe means to communicate and contribute to patient care, surveillance,monitoring, and reduction in alarm frequency in a variety of healthcaresettings. In accordance with various embodiments, methods and systemsfor monitoring consciousness of a patient during sedation, painmanagement, and other monitoring and patient care modalities areprovided.

Various methods and systems are further provided for enablingcommunication between a caregiver or the caregiver environment(including a monitor or other device) and the patient. Applicablescenarios include when the patient is not able to speak or has limitedmotion capabilities or when a clinician or healthcare worker is notphysically present or too preoccupied to provide the prompt, assessment,instruction or care.

In certain embodiments, induced or reduced motion, perfusion or otherartifacts or artifact manipulation in an oximeter probe signal aredetected and analyzed to determine whether a patient is responding to aquery or prompt. According to one method, a patient is provided with apulse oximeter probe, typically on a finger (but embodiments can also beimplemented where the probe is on a toe, nasal septum or other bodypart). The output of the pulse oximeter probe is monitored and analyzedto determine the patient's response to a query or prompt. Thus, invarious embodiments, in addition to using the oximeter to monitor theoxygenation and pulse of the patient, the oximeter is used as part of apatient-in-the-loop system in which the patient can communicate aresponse or initiate an action to a periodic, contextual, timed or otherquery or instruction that may include a menu of choices and therapyinstructions (such as take a deep breath, wiggle your finger three timesif your pain score is greater than x, shift your weight to preventpressure sores, keep your finger still, straighten your arm, move yourleg(s), etc.). Monitoring a patient's perceived pain score is part ofthe Surgical Care Improvement Project (SCIP) measures to monitor qualityof care and compare or benchmark how different institutions ratecompared to each other.

For example, a patient can be prompted (by a person or monitor or otherhealthcare environment device) to squeeze or press his or her fingerwhere the pulse oximeter probe is placed against one or more otherfingers or surface such that the vascular bed inside the pulse oximeteris depressed or squeezed, leading to artifacts (in this case a perfusionartifact) in the photoplethysmogram (the analog waveform indicating theoutput from a photodetector that is part of a pulse oximeter probe).

In another example, the patient can be prompted (by a person or monitoror other healthcare environment device) to wiggle or shake the finger(creating a command-time-linked motion artifact) having the pulseoximeter probe. The squeezing or deliberate shaking or other artifactmanipulation by the patient can also be used to indicate a response to aquery (e.g., to provide a “yes” answer or a “no” answer to a question orto pick an answer or response from a menu of more than two choices).

The motion and/or perfusion artifacts created in the oximeter outputsignal due to the shaking or squeezing by the patient and the temporalrelationship to the prompt/query are used to determine the patient'sresponse or lack thereof.

A system is provided that determines consciousness and/or a non-verbalresponse of a patient according to a deliberately induced artifact in apulse oximeter probe. In one embodiment, the system specifically detectschanges (e.g., the signal degradation or other artifact manipulation) inan output signal of an oximeter caused by the patient squeezing theoximeter probe (or shaking a finger on which the oximeter probe isplaced) shortly after the patient is prompted to do so.

In one embodiment, a patient is prompted to shake the finger on whichthe oximeter probe is placed. In another embodiment, the patient can beprompted to squeeze the finger having the oximeter probe against theopposing thumb, another finger and/or another surface. The fingersqueeze can be sustained or the finger squeeze can be a series ofsqueezes where the number of squeezes corresponds, for example, to thenumber in a menu or a pain score. The intentional shaking or squeezingdeliberately injects or manipulates an artifact into the oximeteroutput. The artifacts in the oximeter output are used to determinewhether the patient responded (and is conscious) and for other functionssuch as confirming that the patient has understood the instruction orindicating that the patient does not understand the instruction:“squeeze once if you understand the instruction; if you did notunderstand the instruction, squeeze twice”. For cyclic motion, peakdetection can be used to determine the response. Other embodiments canutilize Fourier transforms, wavelets and/or pattern recognition and/orfeature extraction algorithms. A “conversation” (including patientresponses) may be carried out with the patient using libraries ofqueries, instruction, prompts and responses.

It should be understood that while the above examples incorporate apulse oximeter, embodiments are not limited to the pulse oximeter andother patient sensors or devices, including, but not limited to, apatient bed, infusion pump, Patient Controlled Analgesia (PCA) pump,blood pressure monitor, ECG, capnometer, capnograph, calf compressiondevice, and a nurse call system, are contemplated within the scope ofthe invention.

For example, in certain embodiments, a PCA pump button may be used toindicate a patient response to a query or prompt. Thus, in variousembodiments, in addition to using the PCA pump to enable a patient tocontrol the administration of analgesia, the PCA pump is used as part ofa patient-in-the-loop system.

In some embodiments, monitoring devices can utilize apatient-in-the-loop approach to enable self-correction for alarms. Amonitoring device (or other device) may sense an impending condition andinstruct, as a first resort, the patient to make a self-correctivemaneuver. Certain alarm conditions can be corrected and/or addressed byoutputting at the monitoring device or some other healthcare environmentdevice to which the monitoring device can communicate with, an alarm orrequest to a patient to respond to instructions such as take a deepbreath, shift your weight, keep your finger still, straighten your arm,move your leg(s), and the like.

This Brief Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Brief Summary is not intended to identify key featuresor essential features of the claimed subject matter, nor is it intendedto be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a system for consciousness monitoring in accordancewith an embodiment of the invention.

FIG. 2 shows a diagram of a patient in-the-loop system in accordancewith various embodiments of the invention.

FIG. 3A shows a diagram of an implementation of a patient-in-the-loopsystem in accordance with an embodiment of the invention.

FIG. 3B shows a diagram of a monitoring system with enhanced monitoringequipment in accordance with various implementations that arecontemplated in accordance with embodiments of the invention.

FIG. 4 shows an example photoplethysmogram of data acquired inaccordance with an embodiment of the invention.

FIGS. 5A and 5B respectively illustrate uphill and downhill curvesformed by acquired data points for explaining a peak detection methodused in an embodiment of the invention.

FIGS. 6A-6C and 7A-7C show plots for explaining a discrete wavelettransform method used in an embodiment of the invention.

FIGS. 8A-8C show plethysmograms from a pulse oximeter in accordance withan embodiment of the invention; FIG. 8A shows a plethysmogram with noartifact, indicating no action by a patient; FIG. 8B shows aplethysmogram when a patient is squeezing the finger with the oximeterprobe repeatedly. The squeezing is cyclic (not constant); each humpcorresponds to a squeeze and release of the finger; and FIG. 8C shows aplethysmogram when a patient is shaking the oximeter. The inducedartifact either appears or disappears following the prompt and thechange in the plethysmogram waveform (ac and/or dc signal) is temporallylinked to the prompt.

FIGS. 9A and 9B respectively show a photograph of a monitor with apressure trace indicative of squeezing a deflated blood pressure cuff inaccordance with an embodiment of the invention and a representation ofthe pressure trace signal.

FIGS. 10A and 10B respectively show a photograph of a monitor with apressure trace indicative of tapping a blood pressure cuff in accordancewith an embodiment of the invention and a representation of the pressuretrace signal.

FIG. 11 shows a functional diagram of a system for consciousnessmonitoring in accordance with a prototype example of an embodiment ofthe invention.

FIG. 12 provides a representation of a pulse oximeter monitor pin out.

FIGS. 13A-13E are photographs of a prototype embodiment of the systemfor consciousness assessment of an embodiment of the invention. FIG. 13Ashows the back panel of a Nellcor™ pulse oximeter monitor; FIG. 13Bshows the wrapper for the Nellcor™ Neonatal-Adult Pulse Oximeter Probeused for the experiments; FIG. 13C shows a front view of the Nellcor™pulse oximeter monitor; FIG. 13D shows an ACCESS I/O data acquisitionboard; and FIG. 13E shows the test set-up.

FIG. 14 shows a diagram of a patient-in-the-loop system enablingself-correction for reducing certain alarms in accordance with anembodiment of the invention.

FIG. 15 illustrates an example implementation of a system enablingself-correction for reducing certain alarms.

DETAILED DISCLOSURE

Methods and systems are disclosed herein that involve a patientin-the-loop approach, enabling a patient to deliberately provide inputor respond to instructions as part of a monitoring system forapplications including consciousness monitoring during sedation, painmanagement and other monitoring and patient care modalities.

In addition to consciousness monitoring, pain management, qualitycontrol and monitoring such as SCIP measures, various implementationsare suitable for care and monitoring applications including, but notlimited to, respiratory care, ECG monitoring, capnography, alarmprevention/management/reduction such as for infusion pumps, pressuresore prevention, incentive spirometry, and deep vein thrombosisprevention.

Furthermore, data derived from these patient-in-the-loop techniques canbe formatted to be received and interpreted by electronic medical record(EMR) and electronic record keeping systems. Example EMR and electronicrecord keeping systems include solutions available from Epic SystemsCorp. and Recordkeepers, Inc as well as OpenEMR available under a GNUGeneral Public License.

The systems described herein can include interfaces for available EMRand electronic record keeping systems so that results from apatient-in-the-loop response can be recorded. In some cases, datacollected and/or analyzed by the described systems can be formatted andinserted or transmitted for recording as part of an electronic record.

Embodiments of the invention use action artifacts or cessation thereofin a pulse oximeter signal caused by deliberate action of a patient asan indicator of a response to a patient query. According to anembodiment, the output signal of a pulse oximeter is analyzed forinduced or terminated artifacts representing a response to verbalcommands.

Pulse oximetry, via a medical device referred to as a pulse oximeter,detects blood pulsation and oxygen in the blood using a non-invasivelight transmittance approach where red and infrared light arealternately directed through a thin vascular bed of a patient to aphotodetector. The absorption of the red and infrared light as it passesthrough the patient to the photodetector is used to indicate oxygenationof the blood. Accordingly, the amount of light detected at thephotodetector can be used to calculate the amount (e.g., ratio) ofoxygen in the blood, as well as the patient's pulse and otherphysiological characteristics. Pulse oximeters use several wavelengthsof light, including red and infrared, because the absorption of the redand infrared wavelengths in the presence of oxygenated hemoglobin(oxyhemoglobin) and hemoglobin (deoxyhemoglobin) are significantlydifferent. The ratio of the absorption of the red and infrared light canbe used to calculate the oxygenation of the blood (e.g., ratio ofoxyhemoglobin to deoxyhemoglobin). The output of a pulse oximeter can beused to provide a photoplethysmogram (PPG) for display on a monitor,enabling healthcare professionals (and others) to obtain a visualindication of the patient's oxygenation (and heart rate).

During pulse oximetry monitoring, artifacts in the signal due to noisein the signal path as well as voluntary and involuntary patient movementare typically removed electronically in order to obtain a more accuratedisplay and calculation of the oxygenation of the patient's blood andthe patient's heart rate measurement. In addition to using the monitoror another device to prompt the patient to remove artifacts from thepulse oximeter's output signal, certain embodiments of the inventionalso take advantage of induced artifacts in the signal to determine apatient's consciousness and/or response to a query or prompt.

Pulse oximeters are quasi-omnipresent in the healthcare setting. Thusembodiments provide an in-the-loop approach for patients without needinganother device (beyond the devices and connections already in thepatient's immediate environment being used to monitor and perform amedical function) for the patient to use. The ability to functionwithout an additional sensor or device can be particularly useful inareas where a query response handgrip is not used or not previouslycontemplated for use.

In addition to pulse oximeters, other embodiments of the inventionutilize other monitors of patient physiological parameters by takinginto consideration artifacts in the monitors' signals caused bydeliberate action of a patient as an indicator of a response to apatient query. Thus, these other existing monitors, sensors or devices,including, but not limited to, electronic beds, infusion pumps, bloodpressure monitors, ECGs, capnometers, capnographs, PCA pumps, calfcompression devices, and nurse call systems, provide other means forpatient-in-the-loop participatory care and/or monitoring where pulseoximeters are not used but where the other existing monitors are incommon use.

In accordance with various embodiments of the invention, the patient'sresponse to a question can be detected through, for example, using apulse oximeter without the need for an additional sensor. The induced orterminated artifacts in the pulse oximeter signal are used as part ofthe patient in-the-loop participatory monitor. A regular pulse oximetersensor can be used without any modifications as was done with theworking model. Instead of modifying existing pulse oximeter probes, asoftware module/upgrade can be added to a pulse oximeter's software inorder to produce and interpret the signal artifacts to provide patientfeedback and enable a determination of patient consciousness when apatient is unable to move or speak or a clinician is absent or otherwiseengaged.

In a further embodiment, an interface is provided to produce the queryprompt via one or more of the five senses, depending on whether thepatient is healthy, deaf, mute, or impaired in some manner. For examplefor an audible prompt, earbud speakers, headphones or direct broadcastspeakers (already incorporated into most monitors and/or at patient carelocations) among others may be used to deliver theprompt/query/instruction. For a visual prompt, a display can providewritten prompts or instructions (in the appropriate language) orgraphical/iconic instructions. For a tactile prompt, in one embodiment,a non-invasive blood pressure cuff can be inflated or pulsated in a waythat distinguishes the cuff manipulation indicating a prompt from theregular cuff inflation or some other tactile stimulus could be used. Forexample, a pain or electrical stimulus may be delivered by a nervestimulator (and which may already be present in the healthcareenvironment of the patient).

According to certain embodiments, a system is provided that determinesconsciousness and/or a non-verbal response of a patient according to adeliberately induced artifact in a pulse oximeter probe signal. In oneembodiment, the system specifically detects changes in an output signalof an oximeter caused by the patient squeezing the oximeter (or shakinga finger on which the oximeter is placed) shortly after the patient isprompted to make or terminate a particular deliberate motion.

FIG. 1 illustrates a system for consciousness monitoring in accordancewith an embodiment of the invention. Referring to FIG. 1, the system 100can have hardware including one or more computer processing units (CPUs)101, memory and/or mass storage (e.g., hard drive) 102, and I/O ports103 a, 103 b. Elements of the computer system hardware can communicatewith each other via a bus 104. The I/O ports can include variousconnectors suitable for connecting various devices for communicationwith the system 100. Although I/O port 1 103 a is shown as a singleinterface, it should be understood that multiple I/O ports may beavailable. For example, I/O port 2 103 b can be provided for connectinga pulse oximeter 105 to the system 100. Other devices that can connectto an I/O port include, but are not limited to a display 106, an inputdevice 107, and a speaker 108. The display can be provided fordisplaying a graphical interface output from the system. The inputdevice 107 can be any suitable input device for enabling a user tointeract with or input data to the system 100. For example, the inputdevice 107 can be a programming interface or a mouse or keyboard. Thespeaker 108 can be provided in the form of a speaker already existing inthe monitor, a headset, earbuds or broadcast speakers.

According to various embodiments, computer-readable instructions forperforming a patient in-the-loop consciousness assessment can be storedin the storage device 102 and accessed for execution by the processor101. Processing modules for execution by the processor 101 can beprovided to read data received from the pulse oximeter 105 via the I/Oport 2 103 b; store the received data at a location in the memory orstorage device 102; and analyze the stored data to determine patientconsciousness (or other particular response). Additional processingmodules can be provided to enable display of the captured (received)data and results of the analysis. In addition, voice samples and/orother sounds or visual, tactile or other cues may be stored in thesystem 100 for output through the speaker 108 or another device via anI/O port.

In a further embodiment, an initial set up for the system includes alearning phase for establishing specific baseline measures, which canprovide additional robustness to the system. For example, no-motion datapoints and deliberate motion or squeeze data points can be establishedduring the learning phase. The no-motion data points can be taken for apredetermined period of time. Similarly the deliberate motion or squeezedata points can be taken for one or more deliberate actions. The one ormore deliberate actions can include, but are not limited to, shaking afinger (having the oximeter probe) for a period of time or a particularnumber of times, alternatingly squeezing and releasing the finger(having the oximeter probe) for a period of time or a particular numberof times, and tapping the finger (having the oximeter probe) for aperiod of time or a particular number of times.

The deliberate artifact data points collection can be aided by using anautomated speaker. For example, the patient can be asked to shake herfinger for a sustained period (e.g., 10 seconds or more) by outputting asound or tone for the sustained period of time. The instructions can begiven in person or by a recording stating, for example, “shake yourfinger and keep shaking it as long as a tone that will follow issounding.”

In one application, the artifacts or lack of artifacts in the outputsignal of a patient's pulse oximeter are assessed to determine the lossof a patient's response to verbal commands. The existence ofinteractive, system-inducible artifacts in the signal indicates aresponsive patient (who is considered to be conscious). However, thedegradation (as in longer time delay or a trend towards longer timedelays between the query and the response) or absence of response can beused as a precursor and early warning of unconsciousness and apnea.

In accordance with certain embodiments of the invention, a patient isinvolved with his or her own monitoring for a variety of monitoringmodalities. For example, a patient can be asked to take a deep breath orhold his or her breath and then provide confirmation that the requestedaction was performed. A confirmation may be obtained via another device(e.g. a capnograph) as well as by pulse oximetry.

In another application, the subject system can use the pulse oximeter asa nurse call button. In one embodiment, the patient can perform aparticular deliberate motion to indicate that a nurse is beingrequested. For example, a patient can shake her finger in 3 quick burststo call a nurse. In such embodiments, the output of the data analysiscan be sent to a nurse station over a network such as a HospitalInformation System (where the system includes a network interface). Inaddition, or as an alternative, an alarm can be sounded. Using theoximeter (or other device configured as part of a patient-in-the-loopsystem) as a potential nurse call button can be handy when the nursecall button is inaccessible by the patient or lost in the bed sheets.

In yet another application, the artifacts in the output signal canprovide pain score documentation. For example, the pulse oximeter canannounce “Please tell us your pain score on a level of 1 to 10. We willslowly count from 1 to 10. When we say the number that is your perceivedpain score, shake your finger” or alternatively “Squeeze your finger thesame number of times as your perceived pain score” and the pain scorelevel is then automatically recorded at periodic intervals with no orminimal clinician time expenditure. In one embodiment, a tactile promptusing a non-invasive blood pressure cuff can be part of a tourniquetpain test in which pain scores (and thus the effect ofsedatives/analgesics) can be obtained via the deliberate inducement ofartifacts in the oximeter output signal as the blood pressure cuff isused to create pain. In yet another embodiment, a blood pressure cuff onthe same arm as the oximeter probe could be inflated during the timethat the patient is being queried. The cuff will cut off circulationand, thus, also the cardiac pulse, providing a cleaner signal (comparedto when the cuff is not inflated). Against this temporary cleanerbackdrop, the induced artifacts can be more readily detected.

FIG. 2 shows a basic diagram of a patient in-the-loop system inaccordance with various embodiments of the invention. The system enablesa two way “conversation” between the patient (who is in the loop) andthe system by outputting a signal and causing a patient to use one ormore of the five senses (hearing/audio, sight/visual, touch/temperature,smell, taste). The system can include a library of prompts (e.g., audioprompts) and a library of responses indicative of deliberatemanipulation of artifacts (motion, breath holding, hyperventilation,facial expressions such as squinting and frowning when using BIS or EEGpads/leads, etc.) to hold the two-way “conversation” between themonitor/system and the patient where the term “conversation”, includingin the figures, encompasses any kind of interaction with the patient.

One or more of warnings, alarms, documentation, quality control,therapy, nurse call, notification, sensor fusion, trend detection,patient condition assessment, and coaching can direct the query orprompt to the user and provide the particular response library uponreceipt and interpretation of the response from the patient in-the-loop.

Examples of the above warnings, alarms, documentation, quality control,therapy, nurse call, notification, sensor fusion, trend detection,patient condition assessment, and coaching are provided as follows andshould not be construed as being limiting.

For example, a warning can be issued when a patient needs a secondprompt to respond or there is a trend towards longer response timesduring consciousness monitoring. An alarm can be sounded where a patientis not responsive to verbal commands during consciousness monitoring.Automatically querying and recording the pain score at prescribedintervals is an example of documentation.

An example of quality control is when an unintended motion artifact isdetected and the patient is asked to keep the hand still and theartifacts disappear, confirming that this was not a sensor defect.Another example of quality control is where a PPG signal and/or a SpO₂value is at or around 85, indicating that the probe has fallen off or ismisplaced. In such an event, a prompt can be made to the patient toplace the pulse oximeter back on the finger and an output provided tothe patient (such as “well done”) when the signal re-appears and thedata indicates that the probe has been successfully reinstalled.

An example of therapy is to periodically instruct the patient to take adeep breath or to shift one's weight. The nurse call can provide arequest for a nurse. An example of notification and of patient conditionassessment is the clinician being notified that the patient is coldbased on automatic query and confirmation. A trend towards an increasein patient reported pain score can be flagged and reported. An exampleof coaching is the detection of a less than optimal breath when asked totake a deep breath and the patient being coached to take a deeper breathor trained over time to develop larger chest expansions.

In an example implementation, the library can include queries includingasking a patient whether he is ready to be extubated. For example, theprompt/query can be triggered by the detection of a motion artifact fromthe pulse oximeter that indicates the patient is waking up or restless.As part of confirming whether the patient is truly ready to beextubated, the query library can be used to ask the questions typicallyasked by clinicians such as “What day is it? Shake your finger (orintroduce other recognizable artifact) when we say the right day. Monday<pause> Tuesday <pause> Wednesday <pause> Thursday <pause> Friday<pause> Saturday <pause> Sunday. Or a simple math problem such as addingtwo single numbers might be asked and afterwards a set of “answers”containing the right answer is slowly enunciated.

Once a response by the patient indicating a successful selection of theday and/or solution to the math problem or other question is received(and determined from the signal), the clinician can be alerted that thepatient has correctly answered the questions indicating he is conscious.

A head lift sustained for 5 seconds or its equivalent may also berequested by the query library and the ability to the patient to performthe action detected by artifacts introduced from the head lift orequivalent (such as raising for 5 seconds the arm with the bloodpressure cuff or the hand with the pulse oximeter probe which willintroduce recognizable artifacts that can be detected by signalanalysis).

According to certain embodiments of the invention, the patientmanipulates deliberate artifacts via a pulse oximeter. In furtherembodiments of the invention, the patient can deliberately “delete”artifacts by stopping motion. For example, if the system (or a user ofthe system) determines that the signal is suspicious, the patient can berequested to stop moving the hand having the pulse oximeter probe or theprobe can be shielded from bright light or replugged.

FIG. 3A illustrates a diagram of an implementation of apatient-in-the-loop system in accordance with an embodiment of theinvention. The Patient Conversation Module functions to enable thepatient interaction. The Patient Conversation Module can be implementedas hardware, software, or a combination of hardware and software that isintegrated with or separate from the existing monitors.

FIG. 3B illustrates various implementations that are contemplated inaccordance with embodiments of the invention. As shown in FIG. 3B, apatient conversation module can be integrated internally or externallywith one or more existing monitors (e.g., one or more of a pulseoximeter, non-invasive blood pressure monitor (NIBP), peripheral nervestimulator, capnograph, pressure monitor, flow monitor, volume monitor,electrocardiograph/transthoracic impedance plethysmograph, respiratoryrate monitor, electromyograph (EMG), and/or some other monitor) andcommunicated to a caretaker, clinician or other provider via aninterface, sensor fusion or hospital information system along with theoutput of the existing monitor.

Sensor fusion refers to embodiments where data or an artifact reportedby one sensor A (such as pulse/heart rate in pulse oximeter) isconfirmed by at least another independent sensor B (for example ECG) orsensor C (for example NIBP) using preferably another measurementprinciple) to confirm a measurement/artifact. Sensor fusion enables ahigher level of confidence that the prompted artifacts (in response toprompts/queries/instructions are in fact the artifacts being sought andnot actually random artifacts (false positives or false negatives).

Various pulse oximeter implementations have already been described.According to an embodiment using a blood pressure cuff (e.g, NIBP),deliberate tapping or squeezing by the patient can be used. In the bloodpressure cuff implementation, the cuff tap and cuff squeeze can becarried out in a similar fashion as described with respect to the pulseoximeter implementation. As seen in FIGS. 9A-9B and 10-10B, themorphology of the waveforms corresponding to the taps and the squeezesare distinctly different. The tap produces a sharper spike-like bumpwhereas the squeeze produces a more rounded bump. This distinctive shapebetween taps and squeezes could be used in an analogous way as dots anddashes in a telegraphic code.

In one implementation, a controller for the NIBP is configured to placethe NIBP machine on venipuncture setting during a query response. Whenin venipuncture setting, the cuff pressure will be constant ifunperturbed and there will be no artifacts in terms of pressure changesor oscillations from an actual NIBP blood pressure measurement cycle todeal with during a query response. Thus perturbations during the queryresponse cycle that occur within an allowed time window after a querymay be interpreted with a higher degree of confidence as responses fromthe patient.

A capnograph (for carbon dioxide monitoring) can be used in place of (orin addition to) a pulse oximeter. For example, whether intubated or withnasal cannula sampling, a patient can be requested to “give a series ofshort exhalations or hold your breath or give a very long and slowexhalation.” The number of short exhalations will show up as the samenumber of small bumps instead of one large bump for a regularexhalation. That is, the patient can be requested to exhale in patternsthat can be uniquely interpreted

Another implementation is a peripheral nerve stimulator with inbuiltaccelerometer (such as the TOF Watch used at UF&Shands). While there isno electrical stimulation, the patient can be prompted to move or shakeor contract or twitch or frown a thumb or other body part (such asfacial muscles) on which the accelerometer is attached in patterns thatcan be uniquely interpreted.

For the pressure monitoring implementation, an intubated patient, e.g.,in the intensive care unit (ICU), can be asked to tighten the chestmuscles to make the thorax compliance stiffer resulting in a higherpressure than baseline inspiratory pressure during inhalation; or askedto take a deep breath or series of small breaths with resulting pressuredips and detect and interpret the response by unique patterns in airwaypressure.

For the flow monitoring, an intubated patient, e.g., in the ICU, duringexhalation, can be asked to pause (stop exhaling and then resumeexhaling) a few times so that the exhaled flow rate drops to zero ordips in unique patterns that can be interpreted.

For the volume monitoring, the patient can be asked to do a largerexhalation than usual or to do multiple small exhalations or totemporarily withhold expiration or other patterns that can be uniquelyinterpreted.

For the respiratory rate monitoring, the patient can be asked totemporarily hyperventilate or hypoventilate or breath hold-in patternsthat can be uniquely interpreted.

For the electrocardiograph (ECG), the patient can be requested to, forexample, wiggle or remove an ECG lead as a response. Alternatively,transthoracic plethysmography (TTP) can use the electrical impedanceacross the thorax (measured via the ECG pads/leads) to infer respiratoryeffort and a query/prompt to take a deep breath could be confirmed byECG/TTP (as well as pulse oximetry).

For the electromyograph (EMG), the patient can be asked to twitch,contract or frown at body locations where the EMG sensor is placed tocreate artifacts on the EMG signal in unique patterns that can beinterpreted.

The input, output or probes attached to the patient can be wired orwireless.

In another embodiment, a PCA pump may be incorporated in place of or inaddition to a monitoring device. For example, in certain embodiments, aPCA pump button may be used to indicate a patient response to a query orprompt. The PCA pump button is generally used (e.g., pressed) by apatient whenever the patient feels pain so that pain medication isdelivered at the patient's command. In addition to, or in place of,detecting a response by inferring motion or squeezes or artifacts in asignal, a direct response can be provided by the use of the PCA pumpbutton.

According to an implementation, the pump can be configured to switchmodes of operation so that a patient's use of a button associated withthe pump during a prompted “response” does not cause analgesic to bedispensed.

In one scenario, the PCA pump processor can be configured to ask thepatient after receiving an indication that the patient hasself-administered a PCA bolus (after an appropriate wait time based onPK/PD) about the perceived pain score using a response system designedto work with the PCA pump.

In another scenario, the PCA pump can be used with integrated monitoringequipment such as a pulse oximeter with patient-in-the-loopparticipatory care and monitoring where the processor for the PCA pumpis configured to use a first button push for participatory feedback anda subsequent button push for administration of a PCA bolus. For example,a PCA button push may first trigger an audio prompt to document theperceived pain score and then when the score has been entered by thepatient deliver the PCA bolus based on the pain score. In some cases,where no response is provided for a certain elapsed time, adetermination may be made that the patient is unconscious (and noanalgesic is delivered).

A comparison of the pre- and post-“PCA button push” pain scores may beperformed in some cases to deduce ratios between PCA requests, PCAdeliveries and successful PCA administrations (those PCS administrationsresulting in a subsequent decrease in pain score).

Thus, in various embodiments, in addition to using the PCA pump toenable a patient to control the administration of analgesia, the PCApump is used as part of a patient-in-the-loop system.

In order to confirm an existence of an artifact and/or improve signalquality, if an unprompted artifact is detected, the system can instructthe patient to “Please stop shaking your finger or moving your hand orarm” or “Please remain still”. If the motion artifact then disappears,this confirms that the signal disruption was due to motion artifact orthe patient being cold and shivering. Based on the plethysmogram for theoximeter output, additional information can be obtained. For example, byanalyzing signal strength, some inferences may be made to the conditionof the patient. In one embodiment, the PPG signal strength can beanalyzed to determine whether there is reduced perfusion due tovasoconstriction and the patient can be asked “if you are cold, shakeyour finger in 4 short bursts.” If a positive response is provided bythe patient (in combination with a determination that there isvasoconstriction), then a message can be provided to the patient'scaregiver (medical or nonmedical) that the patient needs warming.Similarly, a combination of patient response (via artifacts in the pulseoximeter) and sensor outputs (from the pulse oximeter or other sensordevice being used to monitor the patient) can be used to assess andaddress a variety of the patient's needs.

In a further embodiment, the query response can be used as a qualityassurance signal and/or as synergy for extracting the respiratory ratefrom a photoplethysmogram of the oximeter output by determining the lowfrequency oscillations in the PPG signal that corresponds to respirationas opposed to the higher frequency oscillations related to the cardiacpulse. For example, if the query response is indicative that the patientis unresponsive or that there is a trend towards longer lag times beforethe patient responds to a query, then the algorithm extracting therespiratory rate can be made more sensitive as there is an impendinglikelihood of apnea developing. If the query response indicates all isfine, a less sensitive respiratory rate extraction algorithm may be usedthat provides less false alarms.

Embodiments of the invention use artifact detection to determine whethera patient is providing feedback. In one embodiment, consciousnessmonitoring is carried out by searching for the number of peaks in a timeinterval or a set number of samples. Motion can be inferred if thenumber of peaks has increased from the number of peaks found in thesignal before motion was prompted. In another embodiment, patternrecognition is used. In yet another embodiment Fourier transformalgorithms, Fast Fourier Transform (FFT) algorithms or wavelets areused.

In one embodiment, the motion artifact detection involves searching forthe large peaks (beyond those caused by the cardiac pulse) that areadded by finger shaking (motion artifact) to the analogphotoplethysmogram data acquired by the system and discards the smallpeaks caused by noise. FIG. 4 shows an example photoplethysmogram ofdata acquired in accordance with an embodiment of the invention. Todiscard small peaks caused by noise, threshold values can beestablished. For example, if the height of the peak is greater than 10mV while rising up AND greater than 40 mV while going down (see FIG. 4),then it is counted as a peak otherwise it is considered as noise. Itshould be understood that the 10 mV and 40 mV thresholds areprogrammable or learned via artificial intelligence and can be set andadjusted as desired.

For a peak detection algorithm in accordance with an embodiment of theinvention, an array of data points from a pulse oximeter probe, Data[ ],is acquired. Data[1000] contains 1000 samples of data acquired (as fastas possible). From the data contained in the array, peak detection canbe carried out. During initialization the following variables' settingsare made: Temp=Data[0] and flag is set to zero where Data[0]=Data[i=0].Then, successive data points are analyzed for peaks. While consecutivelyiterating through the data, two cases exist. The first case (uphillmovement A-B and downhill movement B-C) is illustrated in FIG. 5A andthe second case (downhill movements B-C and C-D) is illustrated in FIG.5B.

A downhill portion from the peak occurs where the data values aredecreasing (i.e. Data[i]>Data[i+1]). A flag variable is used todifferentiate between downhill movements B-C and C-D in order to definewhich of the downhill movements signifies a peak. The two downhillmovements can each be 40 mV downhill (e.g., at a threshold indicatingdownward movement as opposed to noise); however, to determine whether anuphill movement (e.g., of 10 mV) preceded the downhill movement, a flagis used. In particular, the value of flag is set to 0 (flag=0) when thevalue of Temp increases, e.g., Temp goes from A to B. A value of flag=0means the last step was an uphill movement of at least 10 mV. A value offlag=1 means the last step was a downhill movement.

In the first case, referring to FIG. 5A, A=Data[0]=Temp, and asiterations are performed over Data[ ], the value of Temp increases fromA to B and the value of flag is set to 0. Going from B to C, the valueof Temp decreases by 40 mV or more and the value of flag is 0;therefore, it can be determined that a peak occurred. The peak iscounted (i.e., increment peak count; peak++) and the value of flag isset to 1 (flag=1).

In the second case, referring to FIG. 5B, Temp goes from C to D and thevalue of Temp decreased by 40 mV or more. However, the flag does notequal 0 at this time (due to the value of flag being set to 1 from the Bto C movement) and hence this is not counted as a peak.

While going uphill from A to B, the values of Temp and flag are updated.If the value of Temp is less than Data[i]−10, Temp is updated(Temp=Data[i]) and the flag is set to 0 (flag=0).

In simple words, while going uphill (A to B), update the value ofTemp=Data[i] and set the value of flag=0. While going downhill if theflag is equal to 0 and Temp decreases by 40 mV, count that as a peak andset the value of flag as 1.

While going uphill, the values of Temp and flag are updated only if thevalue of Temp increases by 10 mV, which causes the system to ignore thesmall noise peaks in the data (e.g., C′ of FIG. 4).

The baseline shift in the signal is an induced perturbation. Forexample, a “raise your hand instruction,” will drain blood from thefingers and lead to a baseline shift in what is called the DC componentof the PPG. This baseline shift can be measured and can thus beinterpreted as yet another means for detecting that the patientresponded to a query. The different rates of rise and descent ofartifacts with respect to the physiologic pulse sensed by the pulseoximeter can also be used to differentiate them from cardiac pulses andalso from each other (e.g., NIBB cuff tap verses NIBP cuff squeeze).Accordingly, given a set of real time discrete data points (e.g, 1000data points), the number of peaks can be analyzed and a determinationmade as to whether a patient provided a response. Pseudocode for thealgorithm used for the prototype is shown as follows:

INPUT: Real Time Discrete Data Points

ALGORITHM: Collect 1000 data points in an array Data[1000] from theACCESS I/O board.

Data[0]=A=Temp

Temp goes to B as Data[i] moves from A to B, i.e. while going uphill

If ( Data[i] >= Temp + 10 ) Update Temp and set flag = 0

While going downhill, values of Temp and flag will be updated only whenTemp>=Data[i]+40, and this counts as a peak i.e.

If(Temp >= Data[i] + 40) Temp = Data[i]  if (flag = 0) {peak++; flag =1;}

After iterating over 1000 samples, if the number of peaks is greaterthan 5, then it can be inferred that a deliberate finger shake occurred.

To set the sensitivity, the uphill threshold (i.e. 10 mV) can bechanged, the downhill threshold (i.e. 40 mV) can be changed and thepeaks limit can be increased from 5 to 6 or 7. The process can then berepeated for the next 1000 data points. In addition, the time period forsampling can also be increased.

Temp = Data[0] For all Data points in Data If( Temp + 10 <= Data[i]) {Temp = Data[i] Flag = 0; } Else{ If(Temp >= Data[i] + 40) { Temp = DataIf(Flag == 0) { Flag = 1; Peak++; } } }

It should be noted that the simple algorithm described herein was for aproof of concept working model and is not optimized, nor does the simplealgorithm address whether the photoplethysmogram and heart rate of thepatient change under sedation and what effects these changes may have onthe motion detection algorithm. In addition, other peak detection andvarious signal morphology (e.g., rise/decay, shape of peaks) methods canbe used to identify artifacts in the signal. Localized curve fitting andstandardized moments (e.g., skew and kurtosis), as well as low-passfiltering (such as downsampling and filtering) may be used.

FIGS. 6A-6C and 7A-7C illustrate artifact identification for twosubjects using a discrete wavelet transform approach instead of thesimple peak detection described above. FIGS. 6A and 7A correspondinglyshow the raw signal from a pulse oximeter for a 10 second period ofbaseline, followed by a 10 second period of squeezing the pulse oximeterprobe (a prolonged squeeze) and then a 10 second period withoutsqueezing. FIGS. 6B and 7B show the Haar wavelet based approximation ata two second scale and FIGS. 6C and 7C show the Haar wavelet basedapproximation at a one second scale. The Haar wavelet basedapproximations were obtained by zeroing all detail at scales shorterthan the scale of interest (e.g., 2 second and 1 second scaling) andthen inverse-transforming the scaled signal to obtain a time-domainsignal. In a similar manner, short time fast Fourier transforms (FFTs)can be used for detection of shaking.

According to certain embodiments for conscious sedation andconsciousness monitoring, an initial learning baseline is performed inwhich a patient is asked NOT to move his or her finger. This baselineperiod can be helpful to address situations where the patient has adicrotic notch (2 peaks instead of one per heartbeat) or a fast baselineheart rate. During the initial learning baseline, the number of peaksare counted per second at baseline for a given patient. It is thenpossible to later infer a deliberate artifact if the number of peaks persecond increases by a certain amount or percentage above the baselinelevel within a given time window.

FIGS. 8A-8C show plethysmograms from a pulse oximeter in accordance withan embodiment of the invention. FIG. 8A shows a plethysmogram with noartifact, indicating no action by a patient. FIG. 8B shows aplethysmogram when a patient is squeezing the oximeter. The squeezing iscyclic (not constant); each hump corresponds to a squeeze and release ofthe finger. FIG. 8C shows a plethysmogram when a patient is shaking thefinger with the oximeter probe. The finger shaking is also cyclic; eachhigh frequency hump corresponds to a finger shake. The rate of rise andof descent of the artifacts can be differentiated from native signal andfrom window of time if in response to a prompt.

FIGS. 9A and 9B and 10A and 10B show examples of deliberate artifacts inexisting monitoring equipment. In particular, pressure traces from anon-invasive blood pressure cuff are shown. FIGS. 9A and 9B illustratethe squeezing of the blood pressure cuff and FIGS. 10A and 10Billustrate tapping of the blood pressure cuff.

Once the initial learning baseline is performed, a quality controlsession is performed where the patient is prompted to wag his or herfinger (or perform some other motion) in order to obtain an estimate ofthe frequency of peaks at motion for that patient. Instructions can becarried out using the device speaker. The quality control session can beused to verify that the many elements in the system are appropriate toallow reliable discrimination between response or no response to verbalcommands and to establish a baseline time lag between the audio promptand the detected response at full consciousness. Elements being verifiedinclude whether the speaker/communication is working properly, whetherthe volume is sufficiently loud for the patient to hear any prompts,whether the earbud was properly inserted, whether the patient suffersfrom hearing loss, selection of ear for the earbud (if using only one),comprehension of English or other language and vigor and frequency ofthe wagging, etc. If everything is working and no response is detected,it may be possible to teach the patient how to move their fingerappropriately.

The prompt can be an audio prompt. For example, the pulse oximetersoftware can play an audio clip “Please, shake your finger” and thencount the time between the audio prompt and the finger movement inferredfrom the detected motion artifact.

In one embodiment, after the audio prompt, the system can display theelapsed time in seconds and tenths of a second since the audio prompt.This display can be in graph form or using numbers. The system canindicate the units. For example, if the elapsed time is in seconds, thesystem can indicate that the units are in seconds. When the elapsed timeis in tenths of a second, the display can indicate that the time is intenths of a second by using any suitable nomenclature.

When motion is detected, the system can display an indication thatmotion was detected. For example, the system can output to the display“Responsive to verbal commands within y.z seconds.” If there is noresponse detected after a predetermined period of time (e.g., 5 secondsor 15 seconds), the system can output to the display “Patient seemsunresponsive to verbal commands; audio prompt is being repeated.” At theelapsed predetermined period of time, the audio prompt can be repeated.The repeated audio prompt can be at a louder volume, at a different toneand/or include other stimulus. For example, the system can play an audioclip “Shake your finger NOW!” The second audio clip can be a differentpre-recorded audio clip where the tone is more firm.

If there is no motion detected after first audio prompt and the secondaudio prompt, the system can output to the display “Patient unresponsiveto verbal commands. Check patient immediately!” and sound an alarm. Thealarm can be silenced or disabled once the patient is checked.

In certain embodiments, it can be beneficial to continuously monitorthat a patient is conscious. In one such case, the first prompt (andsecond prompt, if needed) can be applied at a predeterminedclinician-adjustable interval. For example, the patient can be promptedto respond every hour. The regular prompting can be useful for concussedpatients.

A method of using libraries of queries, prompts and instructions andresponses from the patient to enhance quality of care and patient safetyis contemplated. Also contemplated is a method of marking promptedartifacts so that the artifacts can be distinguished from regular outputdata and, where needed, excluded from computed values such as averagesand/or from medical records. For example, because blood pressure isaveraged over time, it can be important for the deliberate artifacts tothe blood pressure signal to not be included in the blood pressurevalues when monitoring the blood pressure. Accordingly, embodiments markand remove the known deliberate artifacts from certain computed bloodpressure values such as mean blood pressure before performing thecalculations providing the mean blood pressure for the patient. This canhelp avoid misdiagnosis or other issues with the patient's medicalrecords such as misinterpretation during medical malpractice litigation.

Further contemplated is a method of removing or reducing long timeaveraging time windows of certain monitoring devices during theresponse/query time frames so that computed values are quickly updatedwithout delay. For example, certain monitoring devices perform averagesof a physiological parameter over a certain window of time (for example,15-30 seconds). This averaging causes a delay between an event and theoutput, which during normal operation is desirable. An example of anaveraging window is during heart rate monitoring where heart rateirregularities in the beating of the heart are averaged over the timewindow to display a relatively stable heart rate that does not wildlyfluctuate. A capnograph also utilizes an averaging time window. However,the prompted artifact data (such as an increased respiratory rate—RR—dueto instructions to the patient to deliberately hyperventilate) duringthe expected response time from the patient may not appear because thewindow might not update the displayed numerical value for RR fast enoughwhen the averaging window in used. Accordingly, embodiments provide amethod in which the averaging window is temporarily disabled to obtainthe instantaneous updates on certain values for the patient-in-the loopresponse determination.

Prototype Example:

FIG. 11 shows a functional diagram of the prototype example. As shown inFIG. 11, the ACCESS I/O board receives input from Analog out 1, Analogout 2, and the pulse oximeter sensor probe (Sensor 1). Real time datacapture was obtained using the ACESS I/O board software functionsADC_GetScanV, which takes the data/voltage from across all the channelsand dumps it into an array passed as a parameter, and ADC_GetChannelV,which takes the data/voltage across one specified channel and stores itinto a double passed as a parameter.

For ADC_GetScanV( ), the first parameter is DeviceIndex which is usuallyzero for the experimental case and the second parameter (channeld) isthe reference to an array into which the function dumps the data. Thus,where there are 16 channels:

-   -   double channeld[16];    -   ADC_GetScanV(DeviceIndex, channeld),

For ADC_GetChannelV( ), the first parameter is the DeviceIndex, thesecond parameter is the channel number from which the data is obtained,and the third parameter (chan) is the reference to variable into whichthe function stores the output value. Thus, when getting the voltageacross channel 1 and storing the voltage to the chan variable, thefunction can be given as:

-   -   double chan;    -   ADC_GetChannelV(DeviceIndex,1,&chan).

The data can be written to a log file by using fprintf and fscanffunctions to read and write from the file. Output will be stored in a“voltage.log” file.

The optional averaging can be carried out by averaging the data over aspecified time period. In order to calculate the average before loggingthe data into a limited size log file, the following formula is used tocalculate the average A_(n) of the first n samples before logging (wherex_(n) is the nth sample).

$A_{n} = {\frac{n - 1}{n}\left\lbrack {A_{n - 1} + \frac{x_{n}}{n - 1}} \right\rbrack}$

Once the data is collected from a channel, discrete data from a selectedchannel is passed to a conscious sedation module for peak detection andprediction of consciousness. For the prototype example, the conscioussedation module carries out the following peak detection algorithm. Thepeak detection algorithm was used to infer motion artifact in real timeif there was more than x peaks (e.g, x=2) detected per 1 second timewindow. To show functionality, a KISS (keep it simple stupid), hardcoded (>x peaks/s=motion) peak detection algorithm was used to detectthe motion.

INPUT: Real Time Discrete Data Points

ALGORITHM: Collect 1000 data points in an array Data[1000] from theACCESS I/O board. Under normal heartbeat, the number of peaks in this1000 sample data set is expected to be 2-4.

Data[0]=A=Temp

Temp goes to B as Data[i] moves from A to B, i.e. while going uphill

If ( Data[i] >= Temp + 10 ) Update Temp and set flag = 0

While going downhill, values of Temp and flag is updated only whenTemp>=Data[i]+40, and this counts as a peak i.e.

If(Temp >= Data[i] + 40) Temp = Data[i]  if (flag = 0) {peak++; flag =1;}

After iterating over 1000 samples, if the number of peaks is greaterthan 5, this can be inferred as a finger shake.

According to the algorithm, the motion artifact detection involvessearching for the large peaks (beyond those caused by the cardiac pulse)that are added by finger shaking (motion artifact) to the analogphotoplethysmogram data acquired via the ACCESS I/O board and discardingthe small peaks caused by noise. If the height of the peak is greaterthan 10 mV while rising up AND greater than 40 mV while going down, thenthe peak is counted as a peak otherwise the peak is considered as noise.However, these 10 mV and 40 mV thresholds are programmable and can beset and adjusted inside the program code. In a normal data collectedover 1000 samples iteration, the data would contain 2-4 peaks; howeverduring data acquisition, if the user is shaking his or her finger, thenumber of peaks in the data would be greater than 5. If the number ofpeaks detected is greater than 5, then it can be concluded that the userwas shaking the finger. However the number of peaks also depends uponfactors such as the values of the thresholds with default values of 10and 40 mV, the baseline heart rate and the typical photoplethysmogramcharacteristics (for example, noise content and presence or absence of adicrotic notch) of the patient.

FIG. 12 provides a representation of a pulse oximeter monitor pin out.The pins are symmetrical; therefore, swapping the two data output pinsprovides a negative voltage. Pin 14 is positive and pin 10 is Ground inthe DB15 connector at the back of the pulse oximeter. The Nellcor™ pulseoximeter monitor used for the experiment has a maximum signal amplitudeof 1000 mV and an average amplitude that ranges between 300-600 mV fornormal heart beat people.

FIGS. 13A-13E show photographs of the experimental set-up. As shown inFIG. 13A, two pins (per the diagram shown in FIG. 12) in the DB 15connector at the top right of the back panel provide thephotoplethysmogram in analog form. The prototype example included acomputer platform; an ACCESS (Acquisition Control CommunicationEngineering/Systems) I/O Board USB-AI16-16A from ACCES I/O Products,Inc.; the Nellcor™ pulse oximeter N-595 SN: G04845129; and Nellcor™Adult SpO2 Sensor 1238033X. The Nellcor™ products are affiliated with aCovidien company.

For patient-in-the-loop participatory care, the patient can bedetermined to have complied with a request such as take a deep breath bydetecting and interpreting the desired artifact in one or more monitorswithin a given time window. In instances of patient-in-the-loopparticipatory care where the action of the patient when complying with arequest may not produce a reliably detectable artifact with the monitorsthat are typically used (such as shifting one's weight to preventpressure sores), the patient can be asked to confirm after a givenelapsed time that is sufficient to perform the action, whether theaction was indeed performed and this can then be recorded (andmarked/distinguished as a patient-entered data verses aclinician-entered data).

In some embodiments, monitoring devices can utilize apatient-in-the-loop approach to enable self-correction for alarms. FIG.14 shows a diagram of a patient-in-the-loop system enablingself-correction for reducing certain alarms in accordance with anembodiment of the invention. Referring to FIG. 14, a self-correction maybe accomplished through a monitoring device (or other device) 1400;alarm module 1410; and user interface 1420, which may involve a speaker1430 (and/or a display).

The monitoring device (or other device) 1400 may sense an impendingcondition and according to the control of an alarm module 1410, instruct(via the user interface 1420) the patient, as first resort, to make aself-corrective maneuver. Certain alarm conditions can be correctedand/or addressed before sending an alarm to bring a clinician to thepatient by outputting at the monitoring device (where the monitoringdevice includes the alarm module and user interface) or some otherhealthcare environment device (providing a user interface/speaker) towhich the monitoring device can communicate with, an alarm or request toa patient to respond to instructions such as take a deep breath, shiftyour weight, keep your finger still, straighten your arm, move yourleg(s), and the like.

For example, an oximeter or other monitor may, in response to adetermination that oxygen saturation is declining, alert and/or promptthe patient to take several deep breaths. If the patient follows theinstruction and/or the oxygen saturation increases and/or returns to anappropriate level, the alarm to a clinician or other health careprovider may be avoided. However, if the corrective maneuver does notprovide the desired result (or no corrective maneuver is performed bythe patient) within a period of time (or the levels pass a certainthreshold), the alarm will be activated. By providing an opportunity forpatient corrective measures prior to sounding an alarm, alarm fatiguemay be substantially reduced.

As another example, such as illustrated in FIG. 15, a kink may exist inan IV line. One illustrative implementation for when a kink occurs,involves the kink being detected by the IV pump's software, which maycurrently indicate detection as a visual yellow (no audio) caution alarm(generally stays on for 15 seconds). If within those 15 seconds, theocclusion is not cleared, the visual alarm may turn from yellow to redand an audible alarm will also be sound. Occlusion of IB tubing may bethe single most common source of IV pump alarms. Therefore, according toan embodiment, there is an opportunity to correct the occlusion beforean audible alarm is sound or immediately after the audible alarm issound (but in some cases before a secondary alert is provided). Inresponse to an infusion pump (e.g., IV pump 1500) measuring a rise inthe outflow pressure of the IV (which may indicate a downstreamocclusion alarm is forthcoming), the IV pump (directly or through adevice or system that the IV pump communicates with) may alert orinstruct the patient to straighten the body part with the IV. The alertmay be output via a speaker 1510 or other user interface incommunication with the IV pump. The IV pump can be considered acontrolling device as it is trying to control a patient condition suchas pain level by administering pain medication. Both monitoring andcontrolling devices fall under patient care devices as well as any otherdevices used in patient care.

Certain techniques set forth herein may be described in the generalcontext of computer-executable instructions, such as program modules,executed by one or more computers or other devices. Certain embodimentsof the invention contemplate the use of a computer system or virtualmachine within which a set of instructions, when executed, can cause thesystem to perform any one or more of the methodologies discussed above.Generally, program modules include routines, programs, objects,components, and data structures that perform particular tasks orimplement particular abstract data types.

It should be appreciated by those skilled in the art thatcomputer-readable media include removable and non-removablestructures/devices that can be used for storage of information, such ascomputer-readable instructions, data structures, program modules, andother data used by a computing system/environment. A computer-readablemedium can be a memory device including, but not limited to, volatilememory such as random access memories (RAM, DRAM, SRAM); andnon-volatile memory such as flash memory, various read-only-memories(ROM, PROM, EPROM, EEPROM), magnetic and ferromagnetic/ferroelectricmemories (MRAM, FeRAM), and magnetic and optical storage devices (harddrives, magnetic tape, CDs, DVDs); or other media now known or laterdeveloped that is capable of storing computer-readable information/data.Computer-readable media should not be construed or interpreted toconsist of propagating signals.

Any reference in this specification to “one embodiment,” “anembodiment,” “example embodiment,” etc., means that a particularfeature, structure, or characteristic described in connection with theembodiment is included in at least one embodiment of the invention. Theappearances of such phrases in various places in the specification arenot necessarily all referring to the same embodiment. In addition, anyelements or limitations of any invention or embodiment thereof disclosedherein can be combined with any and/or all other elements or limitations(individually or in any combination) or any other invention orembodiment thereof disclosed herein, and all such combinations arecontemplated with the scope of the invention without limitation thereto.

It should be understood that the examples and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to persons skilled in theart and are to be included within the spirit and purview of thisapplication.

1. A method of patient participatory care and monitoring, comprising:querying, instructing or prompting a patient to provide a response;receiving a signal from a device monitoring, controlling or sensing acondition of the patient; and analyzing the signal from the device todetermine the patient's response separate from the condition of thepatient being monitored, controlled or sensed.
 2. The method accordingto claim 1, wherein the querying, instructing or prompting of thepatient is performed without active involvement from or in the absenceof a healthcare worker.
 3. The method according to claim 1, furthercomprising: displaying the response of the patient on a monitor.
 4. Themethod according to claim 1, wherein querying, instructing or promptinga patient to provide the response comprises: outputting, via a speaker,at least one audio prompt, instruction or query.
 5. The method accordingto claim 4, wherein outputting the at least one audio prompt instructionor query is performed according to a predetermined interval toperiodically request a response from the patient, the response from thepatient being determined by analyzing the signal from the device.
 6. Themethod according to claim 1, wherein analyzing the signal from thedevice comprises analyzing artifacts in the signal indicating thecondition or response of the patient being monitored, controlled orsensed.
 7. The method according to claim 6, wherein analyzing the signalfrom the device is performed within a specified time window after thequerying, instructing or prompting.
 8. The method according to claim 6,wherein the device is a pulse oximeter, wherein the signal is receivedfrom a pulse oximeter probe, wherein analyzing artifacts in the signalcomprises performing a peak analysis, filtering, or transform of thesignal from the pulse oximeter probe to determine whether the patienthad shaken or squeezed a finger on which the pulse oximeter probe isplaced.
 9. The method according to claim 6, wherein the device is anon-invasive blood pressure monitor, wherein the signal is received froma blood pressure cuff of the non-invasive blood pressure monitor,wherein analyzing artifacts in the signal comprises performing a peakanalysis, filtering, or transform of the signal from the blood pressurecuff to determine whether the patient had squeezed or tapped the bloodpressure cuff.
 10. The method according to claim 6, further comprising:performing a learning phase to establish baseline measures indicative ofno-artifact and deliberate artifact carried out by the patient, thebaseline measures being stored in a memory and accessed during theanalyzing of the artifacts in the output signal to interpret anddetermine the patient's response.
 11. The method according to claim 1,further comprising: in response to detecting an initial pre-alarm or animpending alarm condition from the signal from the device, querying,instructing, or prompting the patient to perform a remedial actionwithout active involvement from or in the absence of a healthcareworker.
 12. A method of patient participatory care and monitoring,comprising: receiving a signal from a device monitoring or controlling apatient; and in response to detecting an initial alarm condition fromthe signal from the device, querying, instructing, or prompting thepatient to perform a remedial action without active involvement from orin the absence of a healthcare worker.
 13. The method according to claim12, wherein the device is an infusion pump.
 14. The method according toclaim 12, further comprising: providing data related to a patient'sresponse or actions to an electronic medical records system.
 15. Apatient in-the-loop monitoring system comprising: a memory device; and aprocessor for reading data received from a pulse oximeter probe via anI/O port, storing the data at a first location in the memory device, andanalyzing the data stored at the first location to determine whether apatient deliberately manipulated artifacts in the data from the pulseoximeter probe.
 16. The system according to claim 15, wherein theprocessor further outputs queries and prompts stored at a secondlocation in the memory device to the patient via a speaker.
 17. Thesystem according to claim 15, further comprising a monitor, wherein theprocessor outputs an image or data for display on the monitor.
 18. Acomputer-readable medium having instructions stored thereon that, whenexecuted, cause a processor to perform a method of patient participatorymonitoring and care comprising: outputting, via a speaker, at least onequery or audio prompt to query, instruct or prompt a patient to providea response; receiving a data from the patient during a time period forproviding the response; and analyzing artifacts in the data to determinethe patient's response.
 19. The computer-readable medium according toclaim 18, further comprising instructions for displaying the patient'sresponse on a monitor.
 20. The computer-readable medium according toclaim 18, wherein outputting the at least one query or audio prompt isperformed according to a predetermined interval to periodically requesta response from the patient, the response from the patient beingdetermined by analyzing the artifacts in the data.
 21. Thecomputer-readable medium according to claim 18, wherein analyzingartifacts in the data comprises performing a peak analysis, filtering ortransform of the data to determine whether the patient had deliberatelymanipulated the probe.